N/A 66800391

GUDID 30040565124224

NPWT Antimicrobial Large Gauze Roll

SMITH & NEPHEW MEDICAL LIMITED

Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll, sterile Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet Woven gauze roll/sheet

• Primary Device ID: 30040565124224
• NIH Device Record Key: f11408e7-3429-4aba-a14e-7fc827b25e79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 66800391
• Catalog Number: 66800391
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040565124223 [Primary]
GS1	30040565124224 [Package]; Contains: 00040565124223; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142979

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-18
• Device Publish Date: 2016-09-20

On-Brand Devices [N/A]

• 30040565124224: NPWT Antimicrobial Large Gauze Roll
• 00040565127132: Foam Wound Dressing
• 30040565127126: Antimicrobial Gauze